Trans-catheter ventricular reconstruction structures, methods, and systems for treatment of congestive heart failure and other conditions

ABSTRACT

Embodiments described herein include devices, systems, and methods for reducing the distance between two locations in tissue. In one embodiment, an anchor may reside within the right ventricle in engagement with the septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor disposed along a surface of the heart. Perforating the exterior wall and the septum from an epicardial approach can provide control over the reshaping of the ventricular chamber. Guiding deployment of the implant from along the epicardial access path and another access path into and through the right ventricle provides control over the movement of the anchor within the ventricle. The joined epicardial pathway and right atrial pathway allows the tension member to be advanced into the heart through the right atrium and pulled into engagement along the epicardial access path.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application a continuation of U.S. patent application Ser. No.15/495,842 entitled “Trans-Catheter Ventricular ReconstructionStructures, Methods, and Systems for Treatment of Congestive HeartFailure and Other Conditions,” filed Apr. 24, 2017, which is acontinuation of U.S. patent application ser. No. 15/130,828 entitled“Trans-Catheter Ventricular Reconstruction Structures, Methods, andSystems for Treatment of Congestive Heart Failure and Other Conditions,”filed Apr. 15, 2016, which is a continuation of U.S. patent applicationSer. No. 14/657,180 entitled “Trans-Catheter Ventricular ReconstructionStructures, Methods, and Systems for Treatment of Congestive HeartFailure and Other Conditions,” filed Mar. 13, 2015, which is a divisionof U.S. patent application Ser. No. 13/632,104 entitled “Trans-CatheterVentricular Reconstruction Structures, Methods, and Systems forTreatment of Congestive Heart Failure and Other Conditions,” filed Sep.30, 2012, which is related to and claims the benefit of the followingU.S. Provisional Patent Applications: Application No. 61/541,624entitled “Trans-Catheter Ventricular Reconstruction Structures, Methods,and Systems for Treatment of Congestive Heart Failure and OtherConditions,” filed Sep. 30, 2011, Application No. 61/541,975 entitled“Remote Pericardial Hemostasis for Ventricular Access and Reconstructionor Other Organ Therapies,” filed Sep. 30, 2011; Application No.61/541,980 entitled “Over-The-Wire Cardiac Implant Delivery System forTreatment of CHF and Other Conditions,” filed Sep. 30, 2011; and U.S.Provisional Patent Application No. 61/541,978 entitled “Cardiac ImplantMigration Inhibiting Systems,” filed Sep. 30, 2011; the full disclosuresof which are incorporated herein by reference in their entirety.

The subject matter of this application is related to that of US PatentPublication No. US2009/0093670, as published on Apr. 9, 2009 andentitled “Treating Dysfunctional Cardiac Tissue;” and to that of USPatent Publication No. US2010/0016655, as published on Jan. 21, 2010 andentitled “Cardiac Anchor Structures, Methods, and Systems for treatmentof Congestive Heart Failure and Other Conditions;” the full disclosuresof which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

The present invention is related to improved medical devices, systems,and methods, with many embodiments being particularly useful forreducing the distance between two points in tissue in a minimally orless invasive manner. Specific reference is made to the treatment of afailing heart, particularly the alleviation of congestive heart failureand other progressive heart diseases. The provided devices, systems, andmethods will often be used so as to resize or alter the geometry of aventricle in a failing heart, such as by reducing its radius ofcurvature through the process of excluding a portion of thecircumference from contact with blood, and thereby reduce wall stress onthe heart and improve the heart's pumping performance. Although specificreference is made to the treatment of congestive heart failure,embodiments of the present invention can also be used in otherapplications in which tissue geometry is altered.

Exemplary embodiments described herein provide implants and methods foralleviating congestive heart failure and other progressive diseases ofthe heart. Congestive heart failure may, for example, be treated usingone or more implants which are selectively positioned relative to afirst wall of the heart (typically an interventricular septum), andanother wall of the heart so as to exclude scar tissue and limit a crosssectional area, or distance across a ventricle. Functional deteriorationof the heart tissues may be inhibited by decreasing a size of the heartchamber and/or approximating tissues so that stress on the tissues islimited. Implant locations and overall chamber remodeling achieved byplacement of a series of implants may be determined so as to provide abeneficial volumetric decrease and chamber shape.

Congestive heart failure (sometimes referred to as “CHF” or “heartfailure”) is a condition in which the heart does not pump enough bloodto the body's other organs. Congestive heart failure may in some casesresult from narrowing of the arteries that supply blood to the heartmuscle, high blood pressure, heart valve dysfunction due to degenerativeprocesses or other causes, cardiomyopathy (a primary disease of theheart muscle itself), congenital heart defects, infections of the hearttissues, and the like. However, in many cases congestive heart failuremay be triggered by a heart attack or myocardial infarction. Heartattacks can cause scar tissue that interferes with the heart muscle'shealthy function, and that scar tissue can progressively replace moreand more of the contractile heart tissue. More specifically, thepresence of the scar may lead to a compensatory neuro-hormonal responseby the remaining, non-infarcted myocardium leading to progressivedysfunction and worsening failure.

People with heart failure may have difficulty exerting themselves, oftenbecoming short of breath, tired, and the like. As blood flow out of theheart decreases, pressure within the heart increases. Not only doesoverall body fluid volume increase, but higher intracardiac pressureinhibits blood return to the heart through the vascular system. Theincreased overall volume and higher intracardiac pressures result incongestion in the tissues. Edema or swelling may occur in the legs andankles, as well as other parts of the body. Fluid may also collect inthe lungs, interfering with breathing (especially when lying down).Congestive heart failure may also be associated with a decrease in theability of the kidneys to remove sodium and water, and the fluid buildupmay be sufficient to cause substantial weight gain. With progression ofthe disease, this destructive sequence of events can cause theprogressive deterioration and eventual failure of the remainingfunctional heart muscle.

Treatments for congestive heart failure may involve rest, dietarychanges, and modified daily activities. Various drugs may also be usedto alleviate detrimental effects of congestive heart failure, such as bydilating expanding blood vessels, improving and/or increasing pumping ofthe remaining healthy heart tissue, increasing the elimination of wastefluids, and the like.

Surgical interventions have also been applied for treatment ofcongestive heart failure. If the heart failure is related to an abnormalheart valve, the valve may be surgically replaced or repaired.Techniques also exist for exclusion of the scar and volume reduction ofthe ventricle. These techniques may involve (for example) surgical leftventricular reconstruction, ventricular restoration, the Dor procedure,and the like. If the heart becomes sufficiently damaged, even moredrastic surgery may be considered. For example, a heart transplant maybe the most viable option for some patients. These surgical therapiescan be at least partially effective, but typically involve substantialpatient risk. While people with mild or moderate congestive heartfailure may benefit from these known techniques to alleviate thesymptoms and/or slow the progression of the disease, less traumatic, andtherefore, less risky therapies which significantly improve the heartfunction and extend life of congestive heart failure patients hasremained a goal.

It has been proposed that an insert or implant be used to reduceventricular volume of patients with congestive heart failure. Withcongestive heart failure, the left ventricle often dilates or increasesin size. This can result in a significant increase in wall tension andstress. With disease progression, the volume within the left ventriclegradually increases and blood flow gradually decreases, with scar tissueoften taking up a greater and greater portion of the ventricle wall. Byimplanting a device which brings opposed walls of the ventricle intocontact with one another, a portion of the ventricle may be excluded orclosed off. By reducing the overall size of the ventricle, particularlyby reducing the portion of the functioning ventricle chamber defined byscar tissue, the heart function may be significantly increased and theeffects of disease progression at least temporarily reversed, halted,and/or slowed.

An exemplary method and implant for closing off a lower portion of aheart ventricle is described in U.S. Pat. No. 6,776,754, the fulldisclosure of which is incorporated herein by reference. A variety ofalternative implant structures and methods have also been proposed fortreatment of the heart. U.S. Pat. No. 6,059,715 is directed to a heartwall tension reduction apparatus. U.S. Pat. No. 6,162,168 also describesa heart wall tension reduction apparatus, while U.S. Pat. No. 6,125,852describes minimally-invasive devices and methods for treatment ofcongestive heart failure, at least some of which involve reshaping anouter wall of the patient's heart so as to reduce the transversedimension of the left ventricle. U.S. Pat. No. 6,616,684 describesendovascular splinting devices and methods, while U.S. Pat. No.6,808,488 describes external stress reduction devices and methods thatmay create a heart wall shape change. US Patent Publication No.US2009/0093670 describes structures and methods for treatingdysfunctional cardiac tissue, while US Patent Publication No.US2010/0016655 describes cardiac anchor structures, methods, and systemsfor treatment of congestive heart failure and Other Conditions. The fulldisclosures of all of these references are incorporated herein byreference in their entirety.

While the proposed implants, systems, and methods may help surgicallyremedy the size of the ventricle as a treatment of congestive heartfailure and appear to offer benefits for many patients, still furtheradvances would be desirable. In general, it would be desirable toprovide improved devices, systems, and methods for treatment ofcongestive heart failure. It would be particularly desirable if suchdevices and techniques could decrease the trauma imposed on collateraltissues when gaining access to the target tissues for treatment, whenpositioning implants and other therapeutic devices for use, and whentreating the target tissue. It would be also be beneficial to enhancethe accuracy of ventricular reconstruction while simplifying the overallprocedure, ideally while decreasing the sensitivity of the therapy onunusual surgical skills. It would be advantageous if these improvementscould be provided without overly complicating the structures of implantsor implant deployment systems, and while significantly enhancing thebenefits provided by the implanted devices.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide improved medical devices,systems, and methods, in many cases for reducing the distance betweentwo locations in tissue, optionally in a less or minimally invasivemanner. The present invention may find specific use in the treatment ofa failing heart, particularly for the alleviation of congestive heartfailure and other progressive heart diseases by reconfiguring abnormalheart geometry that may be contributing to heart dysfunction. In manyembodiments, implant components will be positioned at least partiallywithin a chamber of the heart. For example, an anchor of an implantsystem may, when the system is fully deployed, reside within the rightventricle in engagement with the ventricular septum. A tension membermay extend from that anchor through the septum and an exterior wall ofthe left ventricle to a second anchor along an epicardial surface of theheart. Perforating both the exterior wall and the septum from anepicardial approach can provide beneficial control over the effectivereshaping of the ventricular chamber. Despite this largely epicardialapproach, there are surprising benefits to guiding deployment of theimplant from along both the epicardial access path and another accesspath into and through the right ventricle. For example, controlling themovement of the anchor within the right ventricle from a joinedepicardial pathway and right atrial access pathway can help avoidentangling the anchor with chordea supporting the tricuspid valve andthe like. In fact, despite the epicardial formation of perforationsthrough both the left ventricular exterior wall and the septum, byadvancing the anchor into the heart via the right atrium (optionally viaa femoral or jugular access) behind and axially affixed to the tensionmember, the tension member can then be pulled from the epicardial accesssite. Application of controlled pressure against an epicardial anchorand locking of the implant (ideally both through a working lumen of aminimally invasive epicardial access tool) allows the implant system tobe safely, quickly, and accurately deployed without having to rely oncomplex catheter steering systems within a beating heart or the like.

In a first aspect, the invention provides a method for treating a heartwithin a patient. The heart has first and second chambers with a septumtherebetween, the second chamber having an exterior wall. The methodcomprises advancing a first elongate shaft from outside the patient intothe heart along a first path so that a distal end of the first shaft isdisposed in the first chamber. A second elongate shaft is advanced alonga second path from outside the heart, through the exterior wall andthrough the septum so that a distal end of the second shaft is disposedin the first chamber. The first path is joined to the second path bycoupling the distal end of the first shaft with the distal end of thesecond shaft within the first chamber of the heart. A first anchor andan elongate tension member are advanced into the heart along the joinedpaths, with the tension member being advanced into the first chamber andthe tension member being advanced so as to extend from the first anchorin the first chamber, through the septum, through the second chamber,and through the exterior, and so that an end portion of the tensionmember is disposed outside the heart. A second anchor of the implant iscoupled to the tension member end portion outside the heart. Tension isapplied between the anchors with the tension member so that the anchorsurge the septum and the external wall to engage.

In another aspect, the invention provides a method for treating a heartwithin a patient having congestive heart failure. The heart has firstand second chambers with a septum therebetween, and the second chamberhas an exterior wall. The method comprises advancing a first elongateshaft from outside the patient into the heart along a first path so thata distal end of the first shaft is disposed in the first chamber. Asecond path is formed by advancing a second elongate shaft from outsidethe heart, through the exterior wall and through the septum so that adistal end of the second shaft is disposed in the first chamber. Thedistal end of the first elongate shaft is coupled with the distal end ofthe second elongate shaft within the first chamber of the heart so as tojoin the first path to the second path. A tension member and a firstanchor of an implant are advanced distally into the first chamber of theheart along the first path. The tension member is advanced distally fromthe chamber by pulling a distal end of the tension member along thesecond path so that the tension member extends from the first anchor inthe first chamber, through the septum, through the second chamber, andthrough the exterior wall to the distal end of the tension memberoutside the heart. A second anchor of the implant is coupled to thetension member outside the heart, and tension is applied between theanchors with the tension member so that the septum engages the wall suchthat the congestive heart failure is mitigated.

In another aspect, the invention provides a method for treating a heartwithin a patient having congestive heart failure. The heart has firstand second chambers with a septum therebetween, the second chamberhaving an exterior wall. The method comprises advancing a first elongateshaft from outside the patient into the heart along a first path so thata distal end of the first shaft is disposed in the first chamber. Asecond path is formed by advancing a second elongate shaft from outsidethe heart, through the exterior wall and through the septum so that adistal end of the second shaft is disposed in the first chamber. Thedistal end of the first elongate shaft is coupled with the distal end ofthe second elongate shaft within the second chamber of the heart so asto join the first path to the second path. A first anchor is advanceddistally into the first chamber of the heart along the second path andwithin the first chamber along the first path, wherein the tensionmember trails proximally from the anchor as the anchor is advanceddistally so as to extend from the first anchor in the first chamber,through the septum, through the second chamber, and through the exteriorwall to a proximal end of the tension member disposed outside the heart.A second anchor of the implant is coupled to the tension member outsidethe heart, and tension is applied between the anchors with the tensionmember so that the septum engages the wall.

In a device aspect, the invention provides a system for treating a heartwithin a patient. The heart has first and second chambers with a septumtherebetween, the second chamber having an exterior wall. The systemcomprises a first elongate shaft having a proximal end and a distal end,the distal end of the first shaft being configured to be advanced fromoutside the patient into the heart along a first path so that the distalend of the first shaft is disposed in the first chamber. A secondelongate shaft has a proximal end and a distal end, the distal end ofthe second shaft being configured to be advanced along a second pathfrom outside the heart, through the exterior wall and through the septumso that the distal end of the second shaft is disposed in the firstchamber. A first elongate flexible body is slidably coupled to one ofthe shafts. The first flexible body has a distal end portion configuredfor in situ coupling, within the first chamber of the heart, with acorresponding distal end portion extending from the other of the shaftsso as to join the first path with the second path. An implant isconfigured to be advanced along the joined paths. The implant includes afirst anchor having a low profile configuration for advancement of thefirst anchor along the joined paths. A second anchor is also included inthe implant, along with an elongate tension member having a first endcoupleable with the first anchor and a second end coupleable with thesecond anchor. The first anchor is configured to deploy laterally fromthe low-profile configuration within the first chamber. The tensionmember is configured to extend from the first anchor in the firstchamber, through the septum, through the second chamber, and through theexterior wall such that applying tension between the anchors with thetension member urges the septum and the external wall to engage.

In many embodiments, the first anchor and the tension member areadvanced into the heart while the heart is beating and with the firstanchor axially affixed to the tension member. The first anchor may bedeployed laterally relative to the tension member within the rightventricle, typically from a low profile configuration to a deployedconfiguration which inhibits axial movement of the anchor and tensionmember through the septum. The tension member and the first anchor maybe advanced into the right ventricle of the heart along the first path,and the tension member will then preferably be advanced from the rightventricle along the second path by pulling an end of the tension memberalong the second path through the left ventricle so that the end of thetension member extends outside the heart. Alternatively, the tensionmember and the first anchor may be advanced into the heart along thesecond path, with the tension member trailing from the advancing firstanchor so as to extend through the left ventricle when the first anchoris advanced into the right ventricle. Optionally, a distal portion ofthe tension member and the first anchor may be advanced along the secondpath within a dilating catheter having a dilating distal tip. The anchorcan be laterally released from the dilating catheter by retracting asheath of the dilating catheter proximally from the dilating tip. Inexemplary embodiments the anchor comprises an elongate structurepivotably coupled to the tension member, and the anchor has a guidewirelumen. This allows the anchor to be advanced over a guidewire extendingalong one or both of the paths, thereby providing control over both theorientation and position of the anchor within the chambers of the heart.The guidewire can be withdrawn and the anchor repositioned by pulling atether or the like so that the anchor extends laterally from the tensionmember.

The first path will typically comprise a right atrial path traversingthe right atrium of the heart, with the right atrial path optionallybeing formed using a flexible vascular access device such as byadvancing a catheter or the like through a femoral approach, a jugularapproach, or the like. In some embodiments, an at least semi-rigid shaftmay be used to form the right atrial path, such as by advancing a tissuepenetrating trocar through an external wall of the right atrium into theright atrial appendage. The second path will typically be formed by anat least semi-rigid shaft such as a curved needle, though steerabletissue penetrating catheters such as transceptal access catheters or thelike may alternatively be used. The curved needle may have a sharptissue penetrating tip at the distal end of the second shaft and a lumenextending axially toward the tip.

A first flexible body (such as a guidewire or snare) may optionally beadvanced through or over the first elongate shaft so that an end portionof the first flexible body is disposed in the first chamber. A secondflexible body (such as a guidewire or snare) may also be advancedthrough or over the second elongate shaft so that an end portion of thesecond flexible body is disposed in the first chamber. The coupling ofthe distal end of the first elongate shaft with the distal end of thesecond elongate shaft may be performed by axially coupling the flexiblebodies together within the first chamber of the heart. For example, theaxial coupling of the flexible bodies may be effected by capturing oneof the end portions of one of the flexible bodies within an opening inthe end portion of the other flexible body. The end portion of the otherflexible body may comprise a snare, so that advancing the end portionbeyond a restraining lumen of the associated shaft expands the snare inthe first chamber of the heart so as to expand the opening. An exemplarysnare comprises a basket snare, which is configured to expand byreleasing the basket snare from a lumen of the first elongate shaft sothat the basket snare expands from a low profile insertion configurationto an expanded configuration encompassing a volume of the first chamber.The axial coupling of the flexible bodies may be performed by shrinkingthe opening, typically by withdrawing the opening into the first orsecond shaft. The end portion of the second flexible body can be pulledfrom the first chamber through the first elongate shaft and out of thepatient, with the second flexible body comprising a guidewire having anopposed end. This can leave the guidewire extending from the endportion, into the right ventricle, through the septum, through the leftventricle, through the external wall, and out of the patient to theopposed end. In other embodiments, the other end portion comprises anend portion of the tension member.

When the first anchor is advanced, the first anchor may include anelongate shaft or arm having an axial lumen that is pivotably coupled tothe tension member. The guidewire can help maintain an axial orientationof the anchor, preferably with the arm extending along the tensionmember while the anchor is advanced axially into and within the rightventricle of the heart. The anchor may optionally be advanced intoand/or within the heart using a flexible compressive shaft, sometimesreferred to as a pusher catheter or pushtube. The pusher catheter mayhave separate lumens configured for receiving the guidewire and tensionmember, with both lumens extending between a distal anchor-pushing endand a proximal end. The separate lumens enhance rotational control ofthe anchor about the axis of the tension member, and facilitatesorienting the arms of the anchor by rotating of the pushtube fromoutside the patient. In some embodiments, the tether may have anelongate cross-section and the lumen of the pusher catheter whichreceives the tether may have a corresponding elongate cross-section soas to inhibit rotation of the tether within the lumen and enhancerotational control over the advanced anchor after the guidewire ispulled free of the anchor. In some embodiments a working lumen of anepicardial hemostasis tool may be used to help gain access to anepicardial surface region of the heart. The epicardial region mayencompass the second path through the exterior wall, and the hemostasistool may compress the exterior wall of the heart inwardly around thesecond path so as to inhibit bloodflow from the left ventricle along thesecond path. The second anchor may be advanced toward the epicardialregion through the working lumen.

In many embodiments, post-deployment migration of the anchors may beinhibited by applying a desired anchor force between the tension memberand the second anchor while the second anchor is in a variable forcemode. The second anchor in the variable force mode can slide axiallyproximally and distally along the tension member, and is configured tobe reconfigured from the variable force mode to a set force mode whilethe desired anchor force is applied. The second anchor in the set forcemode inhibits movement of the second anchor along the tension memberaway from the first anchor. The desired anchor force may be applied tothe second anchor by engaging the second anchor through a working lumenof a minimally invasive access tool with a compression shaft, and may bereconfigured from outside the patient body through the working lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a reconstructed left ventricle using a series of implantedanchors so as to mitigate the deleterious effects of congestive heartfailure, according to an embodiment of the invention;

FIG. 1B is a cross-sectional view of the heart of FIG. 1A, showing areduction in the size of the left ventricle effected by one of theimplants;

FIGS. 2A and 2B schematically illustrate minimally invasive access toand endoscopic imaging of a pericardium of the heart;

FIG. 3 schematically illustrates joining of a femoral access tool paththrough the right atrium and an endoscopic trans-epicardial access toolpath by snaring a guidewire within the right ventricle of the heart;

FIG. 3A schematically illustrates introducing a guidewire into a rightventricle of the heart through an external wall of the left ventricleand through the septum so as to form an epicardial access path;

FIGS. 3B and 3C schematically illustrate a needle and guidewire crossingone chamber of a heart and being inserted into another chamber.

FIGS. 4A-4C schematically illustrate joining a right atrial access toolshaft with an endoscopic trans-epicardial access tool shaft within theright ventricle by coupling a guidewire and snare advanced along theshafts and into the right ventricle;

FIGS. 5A and 5B schematically illustrate alternative techniques forjoining a right atrial access tool shaft and an endoscopic epicardialaccess tool by snaring a guidewire within the right ventricle or rightatrium of the heart using a basket snare;

FIG. 6 illustrates a basket snare and associated access catheterconfigured for use in the right ventricle;

FIG. 7 schematically illustrates joining a right-atrial access tool pathwith a trans-epicardial access tool using a snare and associatedguidewire configured for coupling within the pulmonary artery;

FIG. 8 schematically illustrates a guidewire that has been pulled alongpaths joined within the right ventricle so as to extend from outside thepatient, through the right atrium, through the right ventricle, throughthe septum, through the left ventricle, through an exterior wall of theheart, and back outside the patient;

FIGS. 9A-9C schematically illustrates expansion of a path through theleft ventricle over a guidewire, delivery of an anchor and adjacenttension member through the expanded path and over the guidewire, andcontrolling movement and orientation of the anchor within the rightventricle using a guidewire extending along a joined path;

FIGS. 10-10F illustrate components of an over-the-wire implant deliverysystem and their use;

FIGS. 10G-10I illustrate an exemplary an axially flexible helicalscrew-tip dilator and its use for traversing a wall of the heart.

FIGS. 11A-11C illustrate an alternative over-the-wire dilating catheter

FIGS. 12A-12D schematically illustrate introducing an implant into anover-the-wire delivery catheter, advancing the implant into the heartalong the epicardial access path, and deploying the implant within theright ventricle;

FIGS. 13A and 13B schematically illustrate an anchor repositioning leashand its use;

FIGS. 14A-14C schematically illustrate coupling of a tension member to aguidewire so as to facilitate guiding the tension member into andthrough the heart;

FIGS. 15A-15C schematically illustrate advancing the tension member andanchor along a right ventricle access tool over a guidewire, and outfrom the access tool and through the septum and an external wall of theleft ventricle;

FIGS. 16A-16D illustrate an epicardial anchor;

FIGS. 17-21 schematically illustrate imposing a desired anchoring forcewhile an epicardial anchor is in a variable-force mode, andreconfiguring the epicardial anchor to a set force mode so as tomaintain engagement between the septum and the external wall of thebeating heart within a desired range;

FIGS. 21A-D illustrate insertion of an epicardial-engagement portion ofan anchor over a tension member and through a working lumen of aminimally-invasive access device so as to distribute an anchoring loadof an anchor lock along a desired contour;

FIGS. 22A-22D illustrate an epicardial hemostasis tool having a workinglumen to provide access through a tissue tract to a epicardium about anepicardial access path, wherein the tool is configured to compress theexternal wall of the heart toward the access path so as to providehemostasis;

FIGS. 23-24B illustrate alternative epicardial anchors which are adaptedto be advanced along and reconfigured between a variable-force mode anda set force mode via a working lumen of a minimally invasive epicardialaccess device;

FIGS. 25a-28z 3 illustrate deployment of an embodiment of a remoteventricular reconstruction implant in a pig cadaver heart, as describedin the Experimental section;

FIGS. 29a-32c illustrate deployment of an embodiment of a remoteventricular reconstruction implant in a human cadaver heart, asdescribed in the Experimental section;

FIGS. 33a-39b illustrate deployment of an embodiment of a remoteventricular reconstruction implant in a live sheep heart, as describedin the Experimental section;

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods. Exemplary embodiments of the devices are describedfor use in reducing the distance between a region along the septum and aregion of an external wall of the left ventricle of a heart in a less orminimally invasive manner. Hence, embodiments of the tools and methodsdescribed herein may find specific use in the treatment of congestiveheart failure and other progressive heart diseases by reconfiguringabnormal heart geometry that may be contributing to heart dysfunction.For congestive heart failure therapies, perforating both the exteriorwall and the septum from an epicardial approach can provide significantbenefits in control over the locations of implant deployments, therebyeffectively enhancing the resulting reshaping of the ventricularchamber. Despite this largely epicardial approach, there are surprisingbenefits to guiding deployment of the implant from along both theepicardial access path and another access path into and via an accesspath through the right ventricle. This additional right atrial accesspath into the heart may be via the superior vena cava, the inferior venacava, the right atrial appendage, or the like, and the pathways may bejoined together by coupling of a snare to a guidewire or the like withinthe right ventricle, the right atrium, the right pulmonary artery, orthe like. While a variety of tools will be described herein forproviding access pathways, for joining pathways together within theheart, for deploying implants, for maintaining hemostasis, and the like,it should be recognized that alternative embodiments may employadditional or alternative structures, some of which may beoff-the-shelf, and some of which may be new structures configuredparticularly for use in the advantageous therapies described herein. Forexample, embodiments of the systems, implants, and techniques describedherein may employ components described in US2009/0093670, as publishedon Apr. 9, 2009 and entitled “Treating Dysfunctional Cardiac Tissue;”and/or in US Patent Publication No. US2010/0016655, as published on Jan.21, 2010 and entitled “Cardiac Anchor Structures, Methods, and Systemsfor treatment of Congestive Heart Failure and Other Conditions;’ thefull disclosures of which are incorporated herein by reference in theirentirety.

Referring now to FIGS. 1A and 1B, a series of implants 10 are shownimplanted in a heart H so as to decrease a cross-section of a leftventricle LV. Each implant 10 generally includes a first anchor 12, asecond anchor 14, and a tension member 16 coupling the anchors together.Tension in the tension member 16 is transferred from the anchors 12, 14to the septum S and the external wall EW bordering the left ventricle LVso as to bring these structures into engagement, thereby effectivelyexcluding a region of scar tissue ST from the left ventricle. In manyembodiments described herein, implant 10 will be deployed by penetratingthe external wall EW and septum S via a pericardium P of the heart H,and also by accessing a right ventricle RV via a right atrium. Anchorsdeployed within a right ventricle and/or in engagement with the septum Smay sometimes be referred to herein as septal anchors, while anchorsdeployed along the external wall EW of the left ventricle LV may bereferred to as epicardial anchors.

Referring now to FIGS. 2A and 2B an MRI image I taken along viewingplane VP schematically illustrates use of a thoracoscope 20 to provide afield of view encompassing a region of the pericardium of the heart,with the region including a target site for deployment of one or moreepicardial anchors of the implant system.

Referring now to FIG. 3, joining of an access path through the rightatrium to an access path through the pericardium and epicardium bysnaring of a guidewire within the right ventricle under thoracoscopicguidance 20 is schematically illustrated. The right atrial access pathmay extend into the arterial vasculature via the femoral artery FA andinferior vena cava IVC, via the jugular artery JA via the superior venacava, or the like. As can be understood with reference to FIG. 3A, aselected location for perforation of the external wall EW can beidentified using an image from thoracoscope 20, optionally incombination with an image from another imaging modality (such as a prioror contemporaneous image from an ultrasound imaging system, an MRIimaging system, an X-ray or fluoroscopic imaging system, a CT imagingsystem, or the like. In exemplary embodiments, a rigid or semi-rigidshaft of an access tool 22 having a working lumen therethrough isadvanced through the epicardium of the beating heart so that a distalend of the shaft is disposed within the left ventricle LV. Access tool22 may comprise a relatively simple needle or trocar, an may have aproximal hemostasis valve at its proximal end so as to inhibit bloodflowthrough the lumen and facilitate insertion and/or removal of a guidewireand the like. In some embodiments, access tool 22 may have a tissuepenetrating sharpened distal end to facilitate distal insertion, and/ora stylus may be removably disposed within the lumen. Optionalembodiments of access tool 22 may have an energy delivery surface at ornear the distal end so as to deliver radiofrequency energy, laserenergy, or the like to facilitate penetrating the tissue of the externalwall EW. Suitable RF penetrating structures may be commerciallyavailable from (or modified from those available from) Baylis Medical ofToronto Canada.

Still referring to FIG. 3A, access tool 22 may optionally include alaterally deployable structure near the distal end so as to stabilizethe access tool relative to the beating heart tissue around the leftventricle. Suitable deployable stabilizing structures may include amalecott, a pair of opposed deployable arms (optionally similar to thosedescribed below with reference to FIGS. 10B and 10C), or the like. Thelaterally deployable distal structure may be configured for engagementagainst an interior surface of the left ventricle LV or against theepicardial surface of the left ventricle (such as by having thedeployable structure spaced proximally of the distal end). Regardless,once access tool 22 is disposed within the left ventricle, a catheter 24may be advanced through the working lumen of access tool 22, into theleft ventricle, and through a target location of the septum S. Aguidewire 26 will also be inserted through the left ventricle and septumas shown. A variety of structures and techniques can be used forperforating the septum, with the catheter optionally being used topenetrate the septum in some embodiments, with the catheter optionallyhaving a sharpened end, a removable stylus, an energy delivery surface,or the like. When catheter 24 perforates the septum, the catheter willoften have steering capabilities so as to facilitate perforation at atarget location, though in some embodiments catheter 24 may be steeredusing steering capabilities of the guidewire within the working lumen, asteering catheter extending around the catheter and through the workinglumen of access tool 22, or the like. In other embodiments, guidewire 26may be used to perforate through the septum, with the guidewireoptionally having an energy delivery tip and/or steering capabilities,with the catheter being advanced through the septum over the guidewire.Exemplary steerable guidewires with RF penetrating tips include thosecommercially available from (or may be derived from those availablefrom) Baylis Medical of Toronto Canada.

A wide variety of alternative septum perforation approaches might beemployed, including using atrial septum perforation structures andtechniques (or structures and techniques derived therefrom). Forexample, mechanical systems may employ a sharpened distal tip and axialpenetration (such as using structures commercially available from—orstructures derived from—the SafeSept™ transseptal guidewire commerciallyavailable from Adaptive Surgical, LLC; the ACross Transseptal AccessSystem commercially available from St Jude, or the like), a rotatableangled blade, the transseptal puncturing structures and methodsdescribed by Wittkampf et al. in US2011/0087261, or the like. RF systemsmay employ a proprietary tissue penetrating structure or may energize anoff-the-shelf transseptal needle with RF energy, as was described byKnecht et al. in an article entitled “Radiofrequency Puncture of theFossa Ovalis for Resistant Transseptal Access,” Circ ArrhythmElectrophysiol 1, 169 (2008). Laser-energy transseptal approaches mayalso be employed, including structures commercially available from (orderived from those commercially available from) Spectranetics andothers.

Once catheter 24 is advanced through the septum, the working lumen ofthe catheter may be used to access the right ventricle from outside thepatient, with the guidewire optionally being removed and replaced(particularly when the guidewire has been used to perforate the septum)with another guidewire, or remaining for use in joining the accesspaths. To facilitate use of catheter 24 as a right ventricle access tooland swapping guidewires or the like, a hemostasis valve may be providedat a proximal end of the catheter.

Referring now to FIGS. 3B and 3C, still further alternative approachescan be used for perforating the external wall EW and septum S of heart Hvia an epicardial approach so as to form an epicardial access path. Inthis embodiment, a rigid or semi-rigid curved needle 28 is advancedthrough the left ventricle external wall and septum, and guidewire 26 isadvanced through the working lumen of needle 28. A plurality of needlesof different curvatures may be used to form the access pathwaysassociated with the different implants of an implant system, optionallythrough an open surgical approach, a mini-thoracotomy, or the like.Still further alternatives may be employed, including robotic insertionand/or steering of a heart tissue penetrating tool.

Referring now to FIGS. 4A-4C, a distal end of catheter 30 may beadvanced to the right ventricle RV through the right atrium RA andassociated vasculature using known techniques, so that catheter 30provides a right ventricle access tool. Optionally, a snare tool has adistal portion configured to engage a distal portion of the guidewire.For example, distal snare 32 may be separated from a proximal end of asnare body by sufficient length of the snare body to allow the snare tobe manipulated within the right ventricle from the proximal end ofcatheter 30. Snare 32 may be biased to open when advanced beyondcatheter 30, allowing the catheter to be positioned near the septumaround the epicardial path of catheter 24. Advancing guidewire 26through the opening of snare 30 and withdrawing snare 32 into catheter32 so that the guidewire is bent as it enters the distal end of catheter30 axially couples the guidewire to the snare.

Referring now to FIGS. 5A and 5B, there may be advantages to employingalternative elongate flexible bodies to couple the access paths withinthe heart. For example, a guidewire-like elongate body with a proximalend and a distal portion formed as a basket 34 may be expanded in theright ventricle so that the basket encompasses a volume within the rightventricle. In some embodiments, the basket may be withdrawn back intocatheter 24 or 30 so as to capture a guidewire extending from the other,thereby joining the paths. In other embodiments, a guidewire-likeelongate flexible body 36 having short lateral distal protrusion or barbcan be advanced a relatively short distance into a target portion of thebasket and withdrawn back into the catheter so as to capture a member ofbasket 34, with the target portion of the basket being separated fromsensitive heart tissues (such as valve leaflets or chordae) by theexpansion of the basket. Optionally, the basket 34 may be advancedtoward or into the right atrium before engaging the basket with thedistal portion of flexible body 36. An exemplary basket structure andassociated access catheter are shown in FIG. 6.

Referring now to FIG. 7, still alternative distal end portions may beused to help couple the flexible bodies advanced into the heart via theright atrial and epicardial access paths. In this embodiment, catheter30 is advanced through the right atrium and the right ventricle to thepulmonary artery PA. Snare 32 is expanded in the pulmonary artery PA. Adistal balloon 40 mounted to a flexible tubular body 38 is advancedthrough catheter 24 into the right ventricle. Balloon 40 is inflatedfrom a distal end of the flexible body 38 via an inflation lumen of theflexible body, and the balloon is allowed to flow with the blood of theheart into a pulmonary artery PA. The balloon is captured by the snare.Note that the access catheter 24, 30 associated with the variousflexible bodies described above may be switched, so that (for example)balloon 40 may be advanced through catheter 30 along the right atrialaccess path, while snare 32 may be advanced along catheter 24 along theepicardial approach. Regardless of the specific end portions of theflexible bodies employed to axially couple the flexible bodies, couplingof the pathways allows guidewire 26 to be inserted into the body alongone of the paths and withdrawn out of the body from along the other pathso that both a first end 42 and a second end 44 of the guidewire aredisposed outside the heart and the patient. The result is the guidewireextending from a first end disposed outside the patient, into the rightventricle of the heart along the epicardial access path, and back out ofthe heart and the patient through the left ventricle along theepicardial access path, as shown in FIG. 8.

Referring now to FIGS. 9A-10F, deployment of the implant over guidewire26 may optionally include advancing an anchor through external wall EWand/or septum S. While guidewire 26 is shown terminating in rightventricle RV in FIGS. 9A and 9B for simplicity, many or all of the stepsdescribed below may be performed after joining of the access paths sothat the guidewire extends out of the heart through the right atrium. Adilation catheter 50 with a tapered helical distal end 52 can beadvanced over guidewire 26 along the epicardial path, and can be rotatedfrom a proximal end 54 to screw the distal end into and through theseptum from outside the patient, with rotation of catheter 50 optionallybeing transmitted axially over guidewire 26 around a curve. Rotation ofhelical end 52 may help advance catheter 50 with less axial force thanwould be used to axially advance a tapered catheter, and may limit axialforce to the septum sufficiently to inhibit arrhythmia of the heart.Once the path through the septum has been dilated, dilation catheter 50can be withdrawn over guidewire 26 and a distal end 62 of a graspingcatheter 60 can be advanced along the epicardial path over guidewire 26.Grasping catheter 60 has deployable arms 64 which can be withdrawn intoa body 66 of the catheter during insertion, and can be extended axiallyand laterally out of the end of catheter body 66 to a deployedconfiguration (as shown) by actuation of a proximal handle 68 fromoutside the patient. A variety of alternative axial grasping structuresmight also be used, including malecot structures, torroidal balloons, orthe like. Regardless, once distal end 62 of grasping catheter isdisposed within the right ventricle, arms 64 are deployed and thecatheter can be pulled proximally to engage the arms against the septumand facilitate deployment of the septal anchor.

Referring now to FIGS. 10G-10I, and alternative dilation catheter 50′may have a tapered helical distal end 52′ that is configured torotationally advance or screw into and through tissue. Inner and outerconcentric shafts extend proximally of distal end 52 toward a proximalhub 51. The shafts are laterally flexible to accommodate curvature ofthe axis of the dilation catheter, and the hub and tip may be axiallycoupled to the inner shaft and the inner shaft may be sufficientlyaxially stiff so that rotation of the hub outside the body inducescontrolled rotation of the tip into and through the tissue while theouter shaft remains rotationally stationary.

Referring now to FIGS. 9B, 10, 10A, 10F, and 12A, the end of theguidewire extending out from the epicardial access path is threadedthrough a lumen of an anchor delivery 70 from a distal end of thedelivery catheter and out the proximal end. The same guidewire end canthen be inserted through an axial anchor lumen 80 through anchor 12 andwith the anchor aligned along tether 16, the anchor 12 can be loadedinto the proximal end of an anchor delivery catheter 70 over guidewire26 with tether 16 trailing behind the anchor. A pusher catheter 72 canbe positioned proximally of the anchor within delivery catheter 70 topush the anchor distally. The delivery catheter can be advanced alongthe epicardial access path over guidewire 26 so that the distal end ofthe delivery catheter extends into the right ventricle. Optionally, aloading cartridge 82 may facilitate insertion of anchor 12 into deliverycatheter 70. Anchor 12 can then be advanced out of the distal end ofdelivery catheter 70 by pushing the anchor distally with pusher 72.Guidewire 26 helps maintain a position and orientation of the anchorwithin the right ventricle, particularly when the guidewire extendsalong the coupled access paths.

The anchor may optionally be advanced into and/or within the heart bypushing the anchor distally using a flexible compressive shaft of pushercatheter 70 (shown in FIG. 10F), grasping catheter 60 (shown in FIGS.10B and 10C), or the like. In either case, the compressive shaft beingused as a pusher catheter may have separate lumens for the guidewire andtension member as shown, with both lumens extending between the distalanchor-pushing end and the proximal end of the catheter body. More than2 lumens may also be provided, and the multi-lumen structure can enhancerotational control over the anchor about the axis of the tension member,and/or may facilitate orienting the arms of the anchor by rotating ofthe pushtube (optionally along with the tension member and guidewiretherein) from outside the patient. In some embodiments, the tether mayhave an elongate cross-section and the pusher catheter which receivesthe tether may have a corresponding elongate cross-section so as toenhance rotational control over the advanced anchor after the guidewireis pulled free of the anchor, as can be understood with reference to thedistal end of grasper catheter 60 shown in FIG. 10C, and with referenceto the elongate cross-section of the large tether lumen of pushercatheter 70 in FIG. 10F. One or more of the smaller lumens may be sizedto receive the guidewire.

Referring now to FIGS. 11A-11C, an alternative over-the-wire deliverycatheter 90 has a dilating distal tip 92 and a sheath 94 that can bewithdrawn from the distal tip from a proximal handle. When sheath 94 isretracted proximally, anchor 12 is laterally released from a receptacle98 of delivery catheter, allowing catheter to be withdrawn from theaccess path once guidewire 26 has been removed.

Referring now to FIGS. 12D-13B, once anchor 12 is disposed within rightventricle RV and beyond delivery catheter 70, guidewire 26 can beremoved and the anchor can be positioned transverse to tether 16 byengagement between the anchor and the surface of the septum, or bypulling on a leash 100 extending through catheter 24 or catheter 30.Radial positioning of anchor 12 can be provided by rotating the end oftether 16, which remains outside the patient.

Referring now to FIGS. 14A-15C, alternative embodiments of the systemsmay be configured to deliver septal anchor 12 to the right atrium alongthe right atrial path, typically with the anchor trailing behind tether16. An end 102 of tether 16 is generally disposed opposite of anchor 12,and may include features to maintain the tether in alignment along theguidewire, and may also axially couple the tether to the guidewire. Forexample, a channel such as angled channel 104 may receive the guidewiretherein, allowing the tether to be pushed axially over the guidewire.One or more additional channels 106 through tether 16 toward anchor 12from end 102 may help limit bowing of the tether away from guidewire 26when the tether is pushed axially over the guidewire. As can beunderstood with reference to FIGS. 15A-15C, end 102 of tether isadvanced over guidewire 26 and into a proximal hemostasis valve ofcatheter 30. By continuing to push tether 16 into catheter 30, and/or bypulling guidewire 26 from the end extending from the epicardial path,end 102 of the tether may be advanced into and through the septum S andexternal wall EW so that end 102 is disposed outside the heart and thepatient. Optionally, the tether may be advanced along the epicardialpath alongside guidewire 26. In other embodiments, catheter 30 oranother catheter body may be advanced over the guidewire with the tetherdisposed in a lumen.

Referring now to FIGS. 10, 10D, 10E, and 16A-21, epicardial anchor 14has a spring cam structure as more fully described in US PatentPublication No. US2010/0016655, as published on Jan. 21, 2010 andentitled “Cardiac Anchor Structures, Methods, and Systems for treatmentof Congestive Heart Failure and Other Conditions;” the full disclosuresof which are incorporated herein by reference. The spring cam allowsanchor 14 to slide along tether 16 toward anchor 12, but inhibitssliding of anchor 14 away from anchor 12, so that the spring cam caneffective maintains a tissue engagement force between the anchors. Thisset-force interaction between the tether and anchor 14 is advantageousonce the proper force is applied, but it can be challenging to apply thedesired force when the heart is beating. To more accurately applyseptal/external wall engagement forces within a desired range, an anchorset tool 110 can engage the cam spring mechanism of anchor 14 so as toallow the anchor to slide both axial directions along tether 16, therebyconfiguring anchor 14 into a variable force mode. This allows acontrolled force to be applied between the tether 16 and epicardialanchor 14 despite beating of the heart, with the force preferably beingapplied by a force application tool 112 having an elongate shaft 114.Force application tool 14 may be a relatively simple structure similarto a scale, typically having a force spring and an indicator showingwhen a force in a desired range is being applied such as by showingdeflection of the spring to a position within a desired range. Bysliding the shaft of the force application tool over tether 16, engagingthe surface of anchor 14 with a compression surface of the shaft, andapplying force between the tether and the force application tool tillthe desired deflection is identified the desired force may be appliedbetween anchors 12 and 14. While that force is applied, anchor set tool110 may disengage the cam lock of epicardial anchor 14, therebyreconfiguring the anchor from the variable-force mode to the set-forcemode. The force application tool 112 and anchor set tool 112 can then beremoved, the tether 16 extending away from the heart from epicardialanchor can be cut and removed. Pressure by epicardial anchor 14 againstexternal wall 14 inhibits blood flow out of the left ventricle along theepicardial access path, while pressure of septal anchor 12 against theseptum inhibits blood flow from the left ventricle to the rightventricle. Known techniques can be used for closure of the vascularaccess of catheter 30 and the minimally invasive access to theepicardium.

Referring now to FIGS. 21A-21D, a variety of minimally alternativeanchor locking structures and access methods may be employed to decreasecollateral tissue trauma when applying the controlled anchoring force,some of which will be described below. Such minimally invasive anchorlocks may benefit from a tissue-engagement component that distributesanchoring loads laterally between anchors so as to promote apposition ofthe walls of the heart along a desired contour and help provide thedesired ventricular shape after implantation of a multi-anchor implantsystem. Toward that end, a folding anchor component 111 may comprise anat least substantially rigid elongate body having a passage traversingtherethrough, with a channel extending along opposing surfaces of thebody from the aperture. One of the channels may optionally extendthrough the body, allowing the body to be advanced laterally over tether111 so that the tether extends through the body at the passage. Otherembodiments may employ passages in the form of apertures, so that thetether is passed axially through the passage. Regardless, the channelsreceive the tension member so that the anchor component 111 can pivottoward axial alignment with tension member 16, along the anchorcomponent to be advanced over tether 16 through a working lumen of anaccess tool or sheath 113, as shown in FIG. 21B. Once anchor component111 is distal of sheath 113 and proximal of the epicardial surface ofthe heart, the anchor component 111 can be pivoted relative to thetension member and slid distally along the tension member intoengagement with the epicardial surface, as shown in FIGS. 21C and 21D. Arelatively small profile (as compared to the pivoted component 111)locking anchor component can then be advanced axially over the tensionmember through the sheath and into engagement with the anchor component111 so as to provide the desired anchoring force. Anchor component 111may comprise a metal or high-strength polymer structure, such as astainless steel, a Nitinol shape memory alloy, PEEK, or the like.

Referring now to FIGS. 22A-22D, an epicardial access tool may facilitateboth access to the epicardium and hemostasis of the epicardial accesspath. A shaft of the epicardial access tool extends from a proximalhandle to a circumferential series of distal radial compressionfeatures. A working lumen of the access tool shaft allows the variousaccess tools to be advanced along a tissue tract from outside thepatient to an epicardial surface region encompassing the epicardialaccess path. The compression features are oriented to engage tissue ofthe external wall and urge the engaged tissue radially inwardly when thehandle is actuated. In the exemplary embodiment, filaments extendaxially from the handle along the shaft to each compression feature, andthen turn laterally from that compression feature to another compressionfeature. Actuation of the handle pulls the filaments, thereby pullingthe compression features radially inwardly. Alternative epicardialaccess tools may employ suction to grip and stabilize the epicardialsurface of the heart, somewhat analogous to the engagement between knownheart stabilization tools and the heart as used for beating-heartcoronary arterial bypass grafting and the like.

Referring now to FIGS. 23-24B, alternative epicardial anchor structurescan be advanced axially through a working lumen (optionally throughworking lumen of the epicardial hemostasis device described above) andcan also be reconfigured between a set-force mode and a variable-forcemode through the access lumen. Optionally, reconfiguring of theepicardial anchors may be effected by axial rotation of a rotatablefeature with a corresponding feature of a tool extending around thetether (such as the force applying tool described above). Alternatively,a movable actuator may be articulated from along the working lumen.

EXPERIMENTAL Experiment 1 Implantation in a Pig Cadaver Heart #1

A frozen heart was thawed and placed into expanding foam in a positionrepresentative of that in the body seen via a median sternotomy. Avariety of baskets were provided for grasping a guide wire passed intothe right ventricle across the septum from the left ventricle. The shapeof the catheters and baskets varied with target locations along theright ventricular septum that the guide wire would be was to enter.

As shown in FIGS. 25a-c , basket configured to retrieve a wire from theapex of the right ventricular septum, from the mid-portion of the rightventricular septum, and from the infundibulum (pulmonary outflow tract)of the right ventricular septum were provided, respectively.

The apex basket was placed into the right ventricle through the openedright atrium and imaged via fluoroscopy. A curved needle was passedthrough the epicardia surface of the left ventricle (LV) lateral to theLAD, through the LV cavity, across the ventricular septum and into theright ventricle (RV) in the vicinity of the apical basket.

As shown in FIG. 26a the apical basket is placed in the apex of the RVand visualized via fluoroscopy. In FIG. 26b , a needle is passed intothe epicardial surface of the L V and in FIG. 26c is aimed toward thebasket. Following positioning of the needle, a guide wire is passedthrough the needle and into the basket via fluoroscopic control. Thewire position is confirmed in bi-planar views and the needle iswithdrawn. In FIGS. 27a and 27b , the guide wire has been passed throughthe needle and appeared to be within the basket in bi-planarfluoroscopic views, and in 27 c the needle is withdrawn leaving theguide wire in the basket. The guide wire is then grasped by closing thebasket into the guiding catheter and pulling, the guide wire along withthe catheter and closed basket out of the right atrium (see FIGS.28a-28c ).

In FIGS. 28a and b , as the guiding sheath is pushed over the basket,the basket grasps the guide wire and pulls it into the catheter. In FIG.28c the catheter is withdrawn from the right atrium with the attachedguide wire.

This same procedure was then repeated using different baskets andneedles to pass and retrieve guide wires from the mid-portion and theinfundibular portion of the RV septum. Passing and retrieving aguidewire at the mid-RV septal level is shown in FIGS. 28d and 28e , andpassing a retrieving a guide wire at the distal-RV septal (infundibular)level is shown in FIGS. 28f and 28 g.

Positioning Anchors

A tethered anchor was passed over a guide wire to position an anchor onthe RV septal wall; and passing the tether out the LV epicardial surfaceto accept an external anchor. The steps were as follows:

A new guide wire is passed through the LV, septum and RV. It was graspedby a basket within a catheter and is withdrawn out of the RA as shown inFIGS. 28h and 28 i.

A new, wider support sheath was placed over the guide wire underfluoroscopic control and was seen on the epicardial surface (See FIGS.28j and 28k ).

Through that supporting sheath a dilating catheter is passed through theventricular septum and following the guide wire out the epicardialsurface of the heart. See FIGS. 28i -28 n.

While retaining the guide wire within the catheter, the dilator wasremoved and was replaced by an anchor tether passed retrograde by thetether into the catheter, crossing the septum and exiting the LVepicardium. As the anchor approached the sheath, the guide wire waspassed through the alignment hole in the anchor thus aligning the anchorto fit within the hypotube loading cartridge and the sheath. See FIGS.28o -28 s.

The guide wire and tether are then passed into the pusher. Whilemonitoring the progression of the anchor under fluoroscopy the sheath ismaintained near the septum as the anchor is released from the sheath, Atthis point, the tether is manipulated to refine the anchor alignment. Anexternal anchor is than placed over the tether and slid to theepicardial surface and secured in place. Fluoroscopy confirms correctpositioning of the anchor pair. See FIGS. 28t and 28 u. In FIGS. 28v and28w , the anchor has been released from the sheath, aligned andpositioned along the RV septum.

A second anchor pair was then placed more apically than the initialpair. The needle was again passed from a more apical position inrelation to the first anchor. See FIGS. 28x and 28y . As shown in FIG.28z , after sheath and dilator placements the anchor was placed in theRV septum and an external anchor secured the anchor pair in place. Thefinal result is shown in FIGS. 28z-28z 2.

The heart was opened along the right lateral surface beginning in theright atrium and proceeding across the tricuspid valve with care beingtaken to preserve the papillary muscles, moderator band, valve tissueand chordai tendini. The position and deployment of the internal anchorswere inspected and is shown in FIG. 28z 3.

Experiment 2 Implantation in a Human Cadaver Heart

-   67-year-old male. Cause of death: Heart failure-   Serology: NEG-   Height: 71 inches; Weight: 237 lbs

A frozen heart was thawed, placed into expanding foam in a positionrepresentative of that in the body seen via a median sternotomy. Avariety of baskets were provided for grasping a guide wire passed intothe right ventricle across the septum from the left ventricle, asdescribed above.

The surgical approach was from the right atrium (RA). The basket wasplaced into the right ventricle through the opened right atrium andimaged via fluoroscopy. A curved needle was then passed through theepicardial surface of the left ventricle (LV) lateral to the LAD,through the LV cavity, across the ventricular septum and into the rightventricle (RV) in the vicinity of the basket. Following positioning ofthe needle, a guide wire is passed through the needle and into thebasket via fluoroscopic control. The wire position is confirmed inbi-planar views and the needle is withdrawn. The guide wire is thengrasped by closing the basket into the guiding catheter and pulling theguide wire along with the catheter and closed basket out of the rightatrium.

As shown in FIG. 29a , a needle is passed into the epicardial surface ofthe LV and a guide wire is aimed toward the basket. As shown in FIG. 29b, the basket grasps the guide wire and pulls it into the catheter. Asshown in FIG. 29c the catheter is withdrawn from the right atrium withthe attached guide wire.

A new 14 Fr. supporting sheath is placed over the guide wire underfluoroscopic control into the RV. Through that supporting sheath adilating catheter is passed through the ventricular septum and followingthe guide wire out the epicardial surface of the heart.

While retaining the guide wire within the catheter, the dilator is thenremoved and is replaced by an anchor tether passed retrograde by thetether into the catheter crossing the septum and exiting the LVepicardium. As the anchor approaches the sheath, the guide wire ispassed through the alignment hole in the anchor thus aligning the anchorto fit within the hypotube and the sheath.

The guide wire and tether are then passed into the pusher. Whilemonitoring the progression of the anchor under fluoroscopy the sheath ismaintained near the septum as the anchor is released from the sheath. Atthis point, the guide wire is removed allowing the tether to manipulateand to refine the anchor alignment. An external anchor is then placedover the tether and slid to the epicardial surface and secured in place.Fluoroscopy confirms correct positioning of the anchor pair.

As shown in FIG. 30a , the tether has been passed through the sheath,the guide wire has been passed through the anchor and the anchor ispushed through the sheath into the RV. As shown in FIG. 30b , the anchorhas been released from the sheath in the RV. Upon removing the guidewire, the anchor can pivot and is properly aligned along the septum withthe tether. As shown in FIG. 30c , the first anchor pair is deployed.

A second anchor pair was then placed more apically than the initialpair. A median basket was passed from the RA into the RV. A needle waspassed from a more apical position in relation to the first anchor and aguide wire was passed through the LV, septum and aimed toward the basketin the RV. After bi-planar fluoroscopy confirmed the wire within thebasket, it is grasped by the basket within a catheter and is withdrawnout of the RA (see photos below).

As shown in FIG. 31a , the median basket is placed more apical than thefirst anchor pair. As shown in FIG. 31b , a second guide wire is passedthrough the LV, across the septum and is (see FIG. 31c ) grasped by thebasket. As shown in FIG. 31d , the guide wire is brought through thesheath. As shown in FIG. 31e , after the tether is 3 passed retrogradethrough the sheath and the septal anchor released, (see FIG. 31f ) andexternal anchor is placed. The final view shows alignment of the twoanchor pairs.

After sheath and dilator placements the anchor is placed in the RVseptum and an external anchor secures the anchor pair in place.

The heart was opened along the right lateral surface beginning in theright atrium and proceeding across the tricuspid valve with care beingtaken to preserve the papillary muscles, moderator band, valve tissueand chordai tendini. The position and deployment of the two internalanchors were inspected and are shown in FIG. 32 a.

Each right ventricular internal anchor is shown in FIG. 32b or 32 c.

Experiment 3 Implantation in a Live Sheep Heart

-   Weight: 84.7 kg-   Age: adult-   Sex: male

With the animal under general anesthesia, arterial and venous lines wereplaced. The chest was opened through a median sternotomy and thepericardium was opened in the midline. A pericardial cradle was createdand the right atrial (RA) appendage was exposed. A purse-string suture(4-0 Prolene) was placed on the RA and a 14Fr. sheath was passed intothe right ventricle (RV) through the RA under fluoroscopic guidance.

In FIG. 33a , the heart is exposed through a mid-sternotomy andpericardiotomy. The LAD and apex are labeled, and (see FIG. 33b ) atourniquet is place on the RA. A sheath (blue) is passed and underfluoroscopy and (see FIG. 33c ) positioned in the RV (in circle).

An apical basket was passed through the sheath in the RA into the RV,and a needle was passed through the LV epicardium near the apex andaimed toward the basket under fluoroscopic control. A guide wire waspassed through the LV and septum and aimed toward the basket in the RV,After bi-planar fluoroscopy confirmed the wire within the basket, it wasgrasped by the basket within its catheter and was withdrawn out of theRA. A 14Fr. support sheath was then placed over the guide wire.

In FIG. 34a , an apical basket was used to place lowest anchor. In FIG.34b , the guide wire was grasped by the basket and drawn through the RAsheath. In FIG. 34c , the external appearance of the RA sheath with theguide wire exiting the L V epicardium is shown.

Under fluoroscopic control, through the sheath, a dilating catheter waspassed through the ventricular septum and, following the guide wire, outthe epicardial surface of LV of the heart, No bleeding was noted fromeither the entry or exit points of the catheter and no blood entered thecatheter.

While retaining the guide wire within the catheter, the dilator was thenremoved and replaced by an anchor tether passed retrograde at the tetherend into the catheter, crossing the septum and exiting the LVepicardium. As the anchor approached the sheath, the guide wire waspassed through the alignment hole in the anchor thus aligning the anchorto fit within the hypotube and the sheath.

In FIG. 35a , the dilating catheter was passed through the sheath andfollows the guide wire across the ventricular septum and exits on theepicardial surface of LV. In FIG. 35b , the dilator was removed and ananchor tether was passed through the sheath, The end of the tether exitson the epicardial surface. In FIG. 35c , as the anchor approaches thesheath, the guide wire is placed through the hole in the anchor foralignment and entry into the sheath.

The guide wire and tether were passed into the pusher. While monitoringthe progression of the anchor under fluoroscopy the sheath wasmaintained near the septum as the anchor was released from the sheath.At this point, the tether was manipulated to refine the anchoralignment. An external anchor was then placed over the tether and slidto the epicardial surface and secured in place. Fluoroscopy confirmedcorrect positioning of the anchor pair,

In FIG. 36a , the anchor within the hypotube is being placed into thesheath. In FIG. 36b , after the guide wire was removed, the anchor wasreleased and manipulated into proper alignment. In FIG. 36c , anexternal anchor was placed on the tether and secured in place on theepicardium.

Following placement of the first anchor pair, the process was repeatedfor placing a second anchor pair in the mid-portion of the septum. Alasso type basket snare was used to capture the guidewire. Followingthis the second wire was captured as it was passed into the RV. FIGS.37a-37f show the sequence of events for placement of the second anchorpair: (a) the guide wire is captured by the “lasso’ snare and (b)brought out the RA sheath. (c) Shows the guide wire entry site into theLV. (d) A dilator was passed through the sheath over the guide wire andexits the LV (note the absence of bleeding). The anchor tether waspassed through the sheath and with the pusher, the anchor was pushedthrough the sheath. (e) After removing the guide wire, the tether wasmanipulated to refine the anchor alignment under fluoroscopy. (f) Anexternal anchor was then placed over the tether and slid to theepicardial surface and secured in place.

A third set of anchor pairs was then placed more toward the heart base(RV infundibulum). The same “lasso” snare was used for the second anchorpair and grasped the guide wire near the pulmonary outflow tract. Theanimal was then sacrificed. FIGS. 38a-39b show the final anchorpositions in situ and following sacrifice and heart explantation.

Following sacrifice, The heart was then opened along the right lateralsurface beginning in the right atrium and proceeding across thetricuspid valve with care being taken to preserve the papillary muscles,moderator band, valve tissue and chordai tendini, The position anddeployment of the internal anchors were inspected and are shown in FIG.39 a.

The left ventricle was opened to expose the septal surface, The line oftissue exclusion can be seen between the dashed lines of FIG. 39b . Theexclusion line is smooth and complete.

While the exemplary embodiments have been described in some detail forclarity of understanding and by way of example, a variety ofmodification, adaptations, and changes will be obvious to those of skillin the art. Hence, the scope of the present invention is limited solelyby the appended claims.

1. (canceled)
 2. A system for treating a heart within a patient, theheart having a right ventricle and a left ventricle with a septum therebetween, the system comprising: a first catheter having a proximal endand a distal end, the distal end of the first catheter being configuredfor advancement from a first position outside the patient, through thevasculature, and into the right ventricle so that a distal end of thefirst catheter is disposed in the right ventricle; a first member thatis configured for advancement from the distal end of the first catheterso that the first member is positioned within the right ventricle; aneedle having a tissue penetrating tip that is configured foradvancement from a second position outside the patient, through anexterior wall of the left ventricle, and through the septum so that adistal end of the needle is disposed in the right ventricle; a secondcatheter having a proximal end and a distal end, the distal end of thesecond catheter being configured for advancement from the secondposition outside the patient, through a penetration of the needle in theexterior wall of the left ventricle, and through a penetration of theneedle in the septum so that a distal end of the second catheter isdisposed in the right ventricle; a second member that is configured foradvancement from the distal end of the second catheter so that thesecond member is positioned adjacent the first member within the rightventricle; a coupling member that is configured to couple the firstmember and the second member to form a path from the first positionoutside the patient, through the vasculature, through the septum andexterior wall, and to the second position outside the patient; and animplant that includes: a first anchor that is configured for advancementalong the path so that the first anchor is positionable against theseptum; a second anchor; and a tension member having a first end that iscoupleable with the first anchor and a second end that is coupleablewith the second anchor, the tension member being configured to extendfrom the first anchor, through the septum, through the left ventricle,and through the exterior wall so that a distal end of the tension memberis disposed outside the heart and so that applying tension between thefirst and second anchors via the tension member urges the septum and theexterior wall into engagement.
 3. The system of claim 2, wherein thecoupling member is a snare device that is configured to snare the secondmember or the first member to couple the first member and the secondmember to form the path.
 4. The system of claim 3, wherein the firstmember is the snare device and wherein the first member is configured tosnare the second member.
 5. The system of claim 4, wherein the firstmember is configured for advancement from the distal end of the firstcatheter so that the first member is positioned adjacent a pulmonaryartery of the heart, and wherein the first member is configured to snarethe second member adjacent or within the pulmonary artery.
 6. The systemof claim 5, wherein the second member is configured for advancement fromthe distal end of the second catheter in a manner so that the secondmember flows with blood into the pulmonary artery.
 7. The system ofclaim 6, wherein the second member includes a component that enables thesecond member to flow with blood into the pulmonary artery.
 8. Thesystem of claim 4, wherein the second member is a guidewire or a thirdcatheter.
 9. The system of claim 3, wherein the second member is a snaredevice that is positionable adjacent the pulmonary artery, the snaredevice being configured to snare the first member adjacent or within thepulmonary artery.
 10. The system of claim 9, wherein the first member isa guidewire or a third catheter.
 11. The system of claim 2, wherein thefirst catheter is configured so that the first member and the secondmember are insertable through the first catheter so that a distal end ofthe second member is disposed at the first position outside the patient.12. The system of claim 2, wherein the second anchor is slidablymoveable along the tension member, and wherein the second anchor isreconfigurable to inhibit sliding movement of the second anchor alongthe tension member after an anchor force is applied between the firstanchor and the second anchor.
 13. The system of claim 2, wherein thefirst anchor is axially alignable with the tension member in a lowprofile configuration, and wherein the first anchor is pivotable to adeployed configuration in which the first anchor is not axially alignedwith the tension member.
 14. A system for treating a heart of a patientcomprising: a first elongate shaft that is configured for advancementfrom a first position outside the patient and into a right ventricle ofthe heart; a first member that is configured for advancement from thefirst elongate shaft to a position within the right ventricle; a secondelongate shaft that is configured for advancement from a second positionoutside the patient, through a left ventricle wall, and through a septalwall so that a distal end of the second elongate shaft is disposed inthe right ventricle; a second member that is configured for advancementfrom the second elongate shaft to a position within the right ventricleadjacent the first member; a coupling member that is configured tocouple the first member and the second member to form a path from thefirst position outside the patient, through the heart, and to the secondposition outside the patient; and an implant that includes: a tensionmember; a first anchor that is coupled with a first end of the tensionmember and that is configured for advancement along the path so that thefirst anchor is positionable against the septum; and a second anchorthat is slidably coupleable with a second end of the tension member sothat the second anchor is advanceable along the tension member intoengagement with the left ventricle wall and so that an anchor force isachievable between the first and second anchors via the tension memberto urge the septum and the left ventricle wall into engagement.
 15. Thesystem of claim 14, wherein the second elongate shaft is a needle thatis configured to penetrate through the left ventricle wall and theseptal wall.
 16. The system of claim 14, wherein the second elongateshaft is a catheter that includes a tissue penetrating distal end thatis configured to penetrate through the left ventricle wall and theseptal wall.
 17. The system of claim 14, wherein the first member isconfigured for advancement from the first elongate shaft to a positionadjacent a pulmonary artery of the heart.
 18. The system of claim 17,wherein the first member is the coupling member, and wherein thecoupling member is a snare device that is configured to snare the secondmember adjacent or within the pulmonary artery.
 19. The system of claim18, wherein the second member is a catheter or a guidewire.
 20. Thesystem of claim 18, wherein the second member is configured foradvancement from the distal end of the second elongate shaft in a mannerso that the second member flows with blood into the pulmonary artery.21. The system of claim 14, wherein the coupling member is a snaredevice that is configured to snare the first member or the secondmember.